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New rules for MDEL holders: Health Canada’s terms and conditions authority
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
The new UK failure to prevent fraud offence is a game-changing offence. It makes it much easier to prosecute UK and non-UK companies for fraud, and will have a similar impact to the UK Bribery Act (which has resulted in multiple large deferred prosecution agreements under the ”failure to prevent bribery” offence). The UK government has said that it expects the “offence will encourage more companies to implement or improve prevention procedures, driving a major shift in corporate culture to help reduce fraud”.
Many organisations have already started their preparation for the new offence, recognising that the reasonable procedures guidance will be high level, and that the procedures need to be tailored to the risks faced by each organisation.
Let us know if you would like help with understanding the new offence, how it might apply to your organisation or how to approach risk assessments, programme enhancement and training.
Publication
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
Publication
Early January is a good time to take stock of workplace law developments that arose in 2024, and how those developments may evolve in 2025.
Publication
As you prepare for your next AGM, stay up-to-date on key developments in Canadian corporate and securities legislation, corporate governance guidance and institutional shareholder proxy voting guidelines that may impact the management information circular for your 2025 annual shareholder meeting and your 2025 annual disclosure filings.
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